America's Food and Drug Administration (FDA) has issued a warning to the well-known provider of dialysis care and treatment Fresenius about problems with two of its products - Liberty Cycler sets and Naturalyte Acid Concentrate products. The warning is over a claimed failure to deal with products already in the hands of dialysis patients. Apparently the units can leak and although the company is said to have identified the problem and sorted it, units out in the field, so to speak are not having the problem resolved.
If you regularly browse medical news sites, you may have seen this reported in the last few days.
The full warning notice can be viewed at the FDA website. It lists five points that they want corrected within 15 working days.
This is not the first warning that the FDA has issued to Fresenius - there were complaints about their Phoslo gelcaps product three times in the last 18 months.
Tuesday, 12 October 2010
Thursday, 23 September 2010
Drug Shows Hope for Polycystic Kidney Disease Sufferers
A new, experimental drug appears to reduce the size and the number of cysts when tested on mice.
PKD is a common fatal inherited disease, and at the present moment there is no treatment available for it. Eventually it leads to loss of kidney function, and eventually dialysis or a transplant becomes necessary.
By inhibiting a receptor called c-Met, the drug lead to less cyst formation. It was tested by giving the compound to pregnant mice and examining their embryos.
The next stage to continue the research, trying adult mice, other animal models and eventually, check the drug's usefulness in humans. With all drug research, this will be a long and careful process to avoid any side effects.
The research article can be read at The Journal of Clinical Investigation. It's a very technical article, as you'd expect for a research paper.
PKD is a common fatal inherited disease, and at the present moment there is no treatment available for it. Eventually it leads to loss of kidney function, and eventually dialysis or a transplant becomes necessary.
By inhibiting a receptor called c-Met, the drug lead to less cyst formation. It was tested by giving the compound to pregnant mice and examining their embryos.
The next stage to continue the research, trying adult mice, other animal models and eventually, check the drug's usefulness in humans. With all drug research, this will be a long and careful process to avoid any side effects.
The research article can be read at The Journal of Clinical Investigation. It's a very technical article, as you'd expect for a research paper.
Thursday, 9 September 2010
Implantable Artificial Kidney - coming soon
A recent news item immediately caught my eye. It described research led by Dr Shuvo Roy at the University of California San Francisco on an implantable artificial kidney (and another link to the work). The plan is to produce a device the size of a coffee cup.
A filtering membrane will be produced using the same silicon fabrication technology as used in the computer industry to create the fine details of computer chips, allowing very small holes to be created for the filtration process.
Specially engineered compartments, called a BioCartridge, will be created to hold the patient's own kidney cells. This 'bioreactor' part of the device will be grown on the matrix that acts as the filter.
Mr Bole said: 'Those cells will perform the other functions of the original kidney cells, such as regulating vitamin D levels, water levels and metabolic function. So patients would NOT need immunosuppressant drugs because the device will use each patient’s own cells.'
We hear of wearable dialysis machines at regular intervals (our February 2010 post on this topic), but this device could be one step beyond that, and reduce the problems of finding suitable donors for transplants (although we have also posted on methods which allow transplants where the donor is not a close match for the recipient).
A filtering membrane will be produced using the same silicon fabrication technology as used in the computer industry to create the fine details of computer chips, allowing very small holes to be created for the filtration process.
Specially engineered compartments, called a BioCartridge, will be created to hold the patient's own kidney cells. This 'bioreactor' part of the device will be grown on the matrix that acts as the filter.
Mr Bole said: 'Those cells will perform the other functions of the original kidney cells, such as regulating vitamin D levels, water levels and metabolic function. So patients would NOT need immunosuppressant drugs because the device will use each patient’s own cells.'
We hear of wearable dialysis machines at regular intervals (our February 2010 post on this topic), but this device could be one step beyond that, and reduce the problems of finding suitable donors for transplants (although we have also posted on methods which allow transplants where the donor is not a close match for the recipient).
Friday, 20 August 2010
Are you Prepared?
No, this isn't a call for Boy Scouts to come and help, it's about being ready for things going wrong.
Recent research on a large number of dialysis patients shows that most have not taken any measures to safeguard themselves if some sort of disaster occurs (or even thought about it for that matter).
How would you handle an emergency evacuation? In August 2005 Hurricane Katrina threated and then wrecked havoc on a huge number of people. Including more than 5,800 Gulf Coast kidney dialysis patients. Dialysis centres were forced to close. Within a month 148 of these patients had died.
Okay, so you don't live in an area threatened by hurricanes, or tornadoes or earthquakes. What about floods? Even a "small" flood can be a disaster and cut off small villages or towns from the rest of the area. Just this week there was an intense rain storm where I was staying, and the downpour stretched the sewer system to its limits, with some drains overflowing due to the mass of water from nearby areas. It wasn't a disaster by any standards. But if it had been a bit bigger and more wide spread, roads could have become impassible. So how would you get to your dialysis clinic if the roads were flooded? There's a road in the valley I live in that is regularly flooded in bad storms. But I know another couple of roads that are not.
What about fire? Could that make some roads unusable? Of course it could, and it doesn't take a forest fire to do this either! A factory fire could prevent many people using their usual routes around town, and result in other roads being jammed with cars. A train crash could do the same thing.
On an even simpler level - what if your car breaks down - do you have a back-up vehicle available? Perhaps you have arranged with a friend to cover this eventuality, but can they come to you at short notice?
From the above research report:-
So, plan ahead. Have alternative routes to hand, alternative transport readily available. If you are on home dialysis and the local area has some disaster strike, have a plan to get you and your equipment out? Have something in place in case there is an electricity cut. Yes, something as simple and common as that has to be considered as well.
If you live where a natural disaster such as floods can occur, have you enough supplies to keep you going? I don't have all the answers, but it's certainly something you must think about.
Because according to the research done 5 years after Katrina struck, most dialysis patients in that same area are still not prepared for trouble.
I teach people to fly gliders. Before every single take-off we calmly consider everything that might lead to a bad launch and work out what our options are, to reduce the stress. Now it's your turn to do the same.
Recent research on a large number of dialysis patients shows that most have not taken any measures to safeguard themselves if some sort of disaster occurs (or even thought about it for that matter).
How would you handle an emergency evacuation? In August 2005 Hurricane Katrina threated and then wrecked havoc on a huge number of people. Including more than 5,800 Gulf Coast kidney dialysis patients. Dialysis centres were forced to close. Within a month 148 of these patients had died.
Okay, so you don't live in an area threatened by hurricanes, or tornadoes or earthquakes. What about floods? Even a "small" flood can be a disaster and cut off small villages or towns from the rest of the area. Just this week there was an intense rain storm where I was staying, and the downpour stretched the sewer system to its limits, with some drains overflowing due to the mass of water from nearby areas. It wasn't a disaster by any standards. But if it had been a bit bigger and more wide spread, roads could have become impassible. So how would you get to your dialysis clinic if the roads were flooded? There's a road in the valley I live in that is regularly flooded in bad storms. But I know another couple of roads that are not.
What about fire? Could that make some roads unusable? Of course it could, and it doesn't take a forest fire to do this either! A factory fire could prevent many people using their usual routes around town, and result in other roads being jammed with cars. A train crash could do the same thing.
On an even simpler level - what if your car breaks down - do you have a back-up vehicle available? Perhaps you have arranged with a friend to cover this eventuality, but can they come to you at short notice?
From the above research report:-
"End stage kidney disease patients are dependent on medical treatment at regular intervals for their ongoing health, and, as such, are particularly vulnerable to the effects of a disaster. We found that patients on dialysis are largely unprepared for such an event, whether they are forced to stay in their homes or evacuate," said Mark Foster, lead author of the study.
Foster, a UNC medical student, presented the results June 3 at the annual meeting of the Society for Academic Emergency Medicine in Phoenix.So, plan ahead. Have alternative routes to hand, alternative transport readily available. If you are on home dialysis and the local area has some disaster strike, have a plan to get you and your equipment out? Have something in place in case there is an electricity cut. Yes, something as simple and common as that has to be considered as well.
If you live where a natural disaster such as floods can occur, have you enough supplies to keep you going? I don't have all the answers, but it's certainly something you must think about.
Because according to the research done 5 years after Katrina struck, most dialysis patients in that same area are still not prepared for trouble.
I teach people to fly gliders. Before every single take-off we calmly consider everything that might lead to a bad launch and work out what our options are, to reduce the stress. Now it's your turn to do the same.
Tuesday, 27 July 2010
Location, again
And further to the American report (below), a UK newspaper is reporting on the findings of a study which shows that in some areas of the UK, a quarter of patients are put on the transplant waiting list within two years of starting their kidney dialysis treatment, while in other areas more than two thirds are on the list within two years. And that this can not be explained by differences in their state of health.
It looks like the usual, infamous, postcode lottery effect once again. Treatment doesn't depend on your health but your address.
It looks like the usual, infamous, postcode lottery effect once again. Treatment doesn't depend on your health but your address.
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